Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

A comparison of analgesic efficacy and postoperative nausea and vomiting following morphine or fentanyl for perioperative analgesia in paediatric adenotonsillectomy

Acronym

Study hypothesis

To determine whether there is a difference in vomiting episodes or analgesic requirements after use of morphine or fentanyl during adenotonsillectomy operation.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Signs and Symptoms: Vomiting

Intervention

Children aged 5-16 years, American Society of Anesthesiologists (ASA) 1-2 scheduled for adenotonsillectomy will be recruited to the study after obtaining parental consent and verbal assent from the child, if appropriate. They will receive a standard anaesthetic. All children will receive paracetamol and diclofenac for analgesia. At induction all children will receive fentanyl. Intraoperatively they will be randomised to receive either morphine intramuscular (IM) (group M) or fentanyl (group F). Postoperatively they will receive fentanyl or morphine as rescue analgesia. Rescue antiemetic will be given if required. Postoperatively, pain and sedation scores and the number of vomiting episodes in 24 h will be assessed and the intravenous (IV) and oral morphine requirements over 24 h.

Intervention type

Drug

Phase

Not Applicable

Drug names

Morphine, fentanyl

Primary outcome measures

The following outcome measures will be used: pain scores, sedation scores, numbering of vomiting episodes in 24 h, IV and oral opioid requirements in 24 h.